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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982-09-20 to 1982-10-06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted 1981
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)
EC Number:
308-114-5
EC Name:
Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)
Cas Number:
97862-65-2
Molecular formula:
C40H28CrN8O10S2.C28H31N2O3.C20H32N
IUPAC Name:
Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)
Test material form:
solid: particulate/powder
Details on test material:
- Code No.: TK10363
- Batch No.: 42.29
- Physical state: Powder
Specific details on test material used for the study:
- Code No.: TK10363
- Batch No.: 42.29
- Physical state: Powder

Test animals

Species:
rat
Strain:
other: Tif:RAIF (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7 -8 weeks
- Weight at study initiation: 151 - 211 g
- Housing: Animals were caged in groups of 5 in Macrolon cages type 3 with standardised soft wood bedding (Societe Parisienne des sciures, Pantin).
- Diet: Rat food, NAPAG No. 890, NAPAG AG Gossau, Switzerland, provided ad libitum
- Water: Drinking water, provided ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 55 +/- 15
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Distilled water containing 0.5 % carboxymethylcellulose and 0.1 % polysorbate 80
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25, 50, 100 mg/mL vehicle
- Amount of vehicle: 10 mL


Doses:
250, 500, 1000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Statistics:
From the body weights the group means and their standard deviations were calculated. Where feasable, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944).

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
525 mg/kg bw
Based on:
test mat.
95% CL:
> 417 - < 688
Sex:
male
Dose descriptor:
LD50
Effect level:
525 mg/kg bw
Based on:
test mat.
95% CL:
> 345 - < 871
Sex:
female
Dose descriptor:
LD50
Effect level:
525 mg/kg bw
Based on:
test mat.
95% CL:
> 345 - < 871
Mortality:
Males
250 mg/kg bw: no mortalities
500 mg/kg bw: 2 mortalities, both 2 h after treatment
1000 mg/kg bw: 5 mortalities, one at 1h after treatment, four at 2 h after treatment.

Females
250 mg/kg bw: no mortalities
500 mg/kg bw: 2 mortalities, both 2 h after treatment
1000 mg/kg bw: 5 mortalities, one at 1h after treatment, four at 2 h after treatment.
Clinical signs:
No specific symptoms were seen, except for transient clonic- tonic muscle spasms in the animals treated with 500 mg/kg.
Body weight:
No significant changes to the body weights were observed.
Gross pathology:
No compound related gross organ changes were observed. However, due to the colour of the test item, a red discoloration of the whole body was observed during 9 days in the animals treated with 250 mg/kg and during the whole observation period in the animals treated with 500 mg/kg.
Other findings:
The surviving animals recovered within 10 days.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria

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